A Study of BGB-16673 Compared to Investigator's Choice in Participants With Chronic Lymphocytic Leukemia Previously Exposed to Both Bruton Tyrosine Kinase (BTK) and B-cell Leukemia/Lymphoma 2 Protein (BCL2) Inhibitors

Last updated: April 30, 2025
Sponsor: BeiGene
Overall Status: Active - Recruiting

Phase

3

Condition

Chronic Lymphocytic Leukemia

Lymphocytic Leukemia, Chronic

Platelet Disorders

Treatment

Bendamustine

BGB-16673

Rituximab

Clinical Study ID

NCT06846671
BGB-16673-302
2024-518893-15-00
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to investigate the efficacy and safety of BGB-16673 compared with investigator's choice (idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment) in participants with chronic lymphocytic leukemia (CLL) previously exposed to both BTK inhibitors (BTKi) and BCL2 inhibitors (BCL2i).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Confirmed diagnosis of CLL, requiring treatment, based on 2018 internationalworkshop on chronic lymphocytic leukemia (iwCLL) criteria.

  2. Previously received treatment for CLL with a BTKi and BCL2i.

  3. Measurable disease by computer tomography/magnetic resonance imaging

  4. Eastern Cooperative Oncology Group (ECOG) score 0, 1, or 2

  5. Adequate liver function

  6. Adequate blood clotting function

Exclusion

Exclusion Criteria:

  1. Known prolymphocytic leukemia or history of, or currently suspected, Richter'stransformation

  2. Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy inthe last 3 months

  3. Known central nervous system involvement

  4. Prior exposure to any BTK protein degraders

  5. Active fungal, bacterial and/or viral infection requiring parenteral systemictherapy

  6. Clinically significant cardiovascular disease

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Total Participants: 250
Treatment Group(s): 5
Primary Treatment: Bendamustine
Phase: 3
Study Start date:
April 10, 2025
Estimated Completion Date:
February 14, 2030

Study Description

Chronic lymphocytic leukemia is a type of blood cancer that affects people around the world. People with CLL suffer from enlarged lymph nodes, spleen, or liver, or have symptoms like night sweats, weight loss and fever. They have shorter life expectancy compared to healthy people. There is an urgent need for new treatment to prolong life and control disease-related symptoms.

In this study, participants with relapse/refractory (R/R) CLL who were previously exposed to a BTKi and a BCL2i will receive BGB-16673 or the investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment. The main purpose of this study is to compare the length of time that participants live without their CLL worsening between those participants who receive BGB-16673 versus the investigator's choice of treatment (idelalisib plus rituximab or bendamustine plus rituximab, or venetoclax plus rituximab).

Approximately 250 participants will be included in this study around the world. Participants will be randomly allocated to receive either BGB-16673 or the investigator's choice of treatment.

Connect with a study center

  • FUNDALEU

    Caba, CP1114
    Argentina

    Site Not Available

  • Hospital Aleman

    Caba, 1425
    Argentina

    Site Not Available

  • Instituto Alexander Fleming (Iaf)

    Caba, 1426
    Argentina

    Site Not Available

  • Hospital Italiano de Buenos Aires

    Ciudad Autonoma Buenos Aires, 1413
    Argentina

    Site Not Available

  • Instituto Alexander Fleming (Iaf)

    Ciudad Autonoma Buenos Aires, 1426
    Argentina

    Site Not Available

  • Campbelltown Hospital

    Campbelltown, New South Wales 2560
    Australia

    Site Not Available

  • Concord Repatriation General Hospital

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Darling Downs Hospital and Health Service

    Toowoomba, Queensland 4350
    Australia

    Site Not Available

  • Toowoomba Hospital

    Toowoomba, Queensland 4350
    Australia

    Site Not Available

  • The Alfred Hospital

    Melbourne, Victoria 3004
    Australia

    Active - Recruiting

  • Perth Blood Institute

    West Perth, Western Australia 6005
    Australia

    Site Not Available

  • CETUS

    Belo Horizonte, 38082-049
    Brazil

    Site Not Available

  • Cetus Oncologia Santa Casa de Belo Horizonte

    Belo Horizonte, 30575-859
    Brazil

    Site Not Available

  • Hospital Sirio Libanes Brasilia

    Brasilia, 70200-730
    Brazil

    Site Not Available

  • Hospital Erasto Gaertner

    Curitiba, 81520-060
    Brazil

    Site Not Available

  • Centro de Ensino E Pesquisa Em Oncologia de Santa Catarina (Cepen)

    Florianopolis, 88020-210
    Brazil

    Site Not Available

  • Instituto Joinvilense de Hematologia E Oncologia

    Joinville, 89201-260
    Brazil

    Site Not Available

  • Complexo Hospitalar de Niteroi

    Niteroi, 24020-096
    Brazil

    Site Not Available

  • Centro Gaucho Integrado de Oncologia Hospital Mae de Deus

    Porto Alegre, 90110-270
    Brazil

    Site Not Available

  • Complexo Hospitalar de Niteroi

    Rio de Janeiro, 24020-096
    Brazil

    Site Not Available

  • Hospital Sao Lucas Dasa Oncologia

    Rio de Janeiro, 22061-080
    Brazil

    Site Not Available

  • Oncoclinicas Rio de Janeiro Sa

    Rio de Janeiro, 22250-040
    Brazil

    Site Not Available

  • Instituto Brasileiro de Controle Do Cancer

    Sao Paulo, 04014-002
    Brazil

    Site Not Available

  • Instituto Dor de Pesquisa E Ensino Sao Paulo

    Sao Paulo, 04501-000
    Brazil

    Site Not Available

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    Sao Paulo, 05653-120
    Brazil

    Site Not Available

  • Hospital Santa Rita de Cassia Afecc

    Vitoria, 29043-260
    Brazil

    Site Not Available

  • London Health Sciences Centre

    London, Ontario N6A 5W9
    Canada

    Site Not Available

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario K1H 8L6
    Canada

    Site Not Available

  • Centre Integre de Sante Et de Services Sociaux de La Monteregie Centre

    Greenfield Park, Quebec J4V 2H1
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec QC H3t 1E2
    Canada

    Site Not Available

  • Unite de Recherche Clinique Du Cisss Des Laurentides

    SaintJerome, Quebec J7Z 5T3
    Canada

    Site Not Available

  • Fakultni Nemocnice Brno

    Brno, 625 00
    Czechia

    Site Not Available

  • Fakultni Nemocnice Hradec Kralove

    Hradec Kralove, 500 03
    Czechia

    Site Not Available

  • Vseobecna Fakultni Nemocnice V Praze

    Praha, 10000
    Czechia

    Site Not Available

  • Klinikum Augsburg, Ii Medizinische Klinik

    Augsburg, 86156
    Germany

    Site Not Available

  • Praxis Am Volkspark

    Berlin, 10715
    Germany

    Site Not Available

  • Klinikum Chemnitz Ggmbh

    Chemnitz, 09116
    Germany

    Site Not Available

  • St Johannes Hospital

    Dortmund, 44137
    Germany

    Site Not Available

  • Centrum Fur Haematologie Und Onkologie Bethanien

    Frankfurt, 60389
    Germany

    Site Not Available

  • Centrum Fur Haematologie Und Onkologie Bethanien

    Frankfurt am Main, 60389
    Germany

    Site Not Available

  • Universitatsklinikum Hamburg Eppendorf

    Hamburg, 20251
    Germany

    Site Not Available

  • Saarland University Medical Center

    Homburg, 66421
    Germany

    Site Not Available

  • Invo Institut Fur Versorgungsforschung in Der Onkologie

    Koblenz, 56068
    Germany

    Site Not Available

  • Universitaetsklinikum Leipzig Aor

    Leipzig, 04103
    Germany

    Site Not Available

  • Universitatsklinikum Munster Medizinische Klinik A

    Munster, 48149
    Germany

    Site Not Available

  • Irccs Istituto Tumori Giovanni Paolo Ii

    Bari, 70124
    Italy

    Site Not Available

  • Aou Careggi, Servizio Sanitario Toscana

    Firenze, 50134
    Italy

    Site Not Available

  • Ospedale San Raffaele

    Milano, 20132
    Italy

    Site Not Available

  • Aou Maggiore Della Carita

    Novara, 28100
    Italy

    Site Not Available

  • Ospedale Santa Maria Della Misericordia

    Perugia, 6132
    Italy

    Site Not Available

  • Fondazione Policlinico Universitario Agostino Gemelli

    Roma, 00168
    Italy

    Site Not Available

  • Aichi Cancer Center Hospital Clinical Oncology

    Nagoya, Aichi 464-8681
    Japan

    Site Not Available

  • Chiba Cancer Center

    Chibashi, Chiba 260-8717
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa, Chiba 277-8577
    Japan

    Site Not Available

  • Nho Shikoku Cancer Center

    MatsuyamaShi, Ehime 791-0280
    Japan

    Site Not Available

  • Hiroshima Red Cross Hospital and Atomic Bomb Survivors Hospital

    Hiroshimashi, Hiroshima 730-8619
    Japan

    Site Not Available

  • Aiiku Hospital

    Sapporo, Hokkaido 064-0804
    Japan

    Site Not Available

  • Aiiku Hospital

    SapporoShi, Hokkaido 064-0804
    Japan

    Site Not Available

  • Hyogo Prefectural Amagasaki General Medical Center

    AmagasakiCity, Hyogo 660-8550
    Japan

    Site Not Available

  • Kagoshima University Hospital

    Kagoshimashi, Kagoshima 890-8520
    Japan

    Site Not Available

  • University Hospital, Kyoto Prefectural Univ of Medicine

    KyotoShi, Kyoto 602-8566
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendaishi, Miyagi 980-8574
    Japan

    Site Not Available

  • Niigata University Medical and Dental Hospital

    Niigatashi, Niigata 951-8520
    Japan

    Site Not Available

  • Kurashiki Central Hospital

    Kurashikishi, Okayama 710-8602
    Japan

    Site Not Available

  • Kansai Medical University Hospital

    Hirakata, Osaka 573-1191
    Japan

    Site Not Available

  • Kindai University Hospital

    Osakasayama, Osaka 589-8511
    Japan

    Site Not Available

  • Saitama Medical Center

    Kawagoeshi, Saitama 350-8550
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuoku, Tokyo 104-0045
    Japan

    Site Not Available

  • Ntt Medical Center Tokyo

    Shinagawaku, Tokyo 141-0022
    Japan

    Site Not Available

  • Kumamoto University Hospital

    Kumamoto, 860-8556
    Japan

    Site Not Available

  • University Hospital, Kyoto Prefectural Univ of Medicine

    Kyoto, 602-8566
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192
    Japan

    Site Not Available

  • Osaka Metropolitan University Hospital

    Osaka, 545-8586
    Japan

    Site Not Available

  • Dong A University Hospital

    Busan, Busan Gwang'yeogsi 49201
    Korea, Republic of

    Site Not Available

  • Dong A University Hospital

    SeoGu, Busan Gwang'yeogsi 49201
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    Daegu, Daegu Gwang'yeogsi 41944
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Hospital

    JungGu, Daegu Gwang'yeogsi 41944
    Korea, Republic of

    Site Not Available

  • National Cancer Center (Korea)

    Goyang-si, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • National Cancer Center (Korea)

    IlsandongGu GoyangSi, Gyeonggi-do 10408
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    HwasunGun, Jeollanam-do 58128
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    GangnamGu, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St Marys Hospital

    SeochoGu, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul Teugbyeolsi 06351
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul, Seoul Teugbyeolsi 03080
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St Marys Hospital

    Seoul, Seoul Teugbyeolsi 06591
    Korea, Republic of

    Site Not Available

  • Centro de Investigacion Clinica Gramel

    Mexico, 3720
    Mexico

    Site Not Available

  • Christus Latam Hub Center of Excellence and Innovation Sc

    Monterrey, 64000
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca, 68020
    Mexico

    Site Not Available

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca De Juarez, 68020
    Mexico

    Site Not Available

  • North Shore Hospital

    Auckland, 0622
    New Zealand

    Site Not Available

  • North Shore Hospital

    Takapuna, 0622
    New Zealand

    Site Not Available

  • Szpital Specjalist W Brzozowie,Podkarpacki Osrodek Onkologiczny

    Brzozow, 36-200
    Poland

    Site Not Available

  • Pratia Onkologia Katowice

    Katowice, 40-519
    Poland

    Site Not Available

  • Pratia McM Krakow

    Krakow, 30-727
    Poland

    Site Not Available

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    Lodz, 93-510
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Nr W Lublinie

    Lublin, 20-090
    Poland

    Site Not Available

  • Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M Kopernika W Lodzi

    OD, 93-513
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wrocaw, 50-556
    Poland

    Site Not Available

  • Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu

    Wroclaw, 50-556
    Poland

    Site Not Available

  • Sahlgrenska Universitetssjukhuset

    Goteborg, 416 85
    Sweden

    Site Not Available

  • Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital

    Ankara, 06200
    Turkey

    Site Not Available

  • Gazi University

    Ankara, 6500
    Turkey

    Site Not Available

  • Antalya Memorial Hospital

    Antalya Memorial Hospital, 07025
    Turkey

    Site Not Available

  • Dokuz Eylul University

    Balcova, 35330
    Turkey

    Site Not Available

  • Antalya Memorial Hospital

    Dokuma, 07025
    Turkey

    Site Not Available

  • Dokuz Eylul University

    Izmir, 35340
    Turkey

    Site Not Available

  • Aberdeen Royal Infirmary

    Aberdeen, AB25 2ZN
    United Kingdom

    Site Not Available

  • Birmingham Heartlands Hospital

    Birmingham, B9 5SS
    United Kingdom

    Site Not Available

  • The Royal Bournemouth and Christchurch Hospitals Nhs Foundation

    Bournemouth, BH7 7DW
    United Kingdom

    Site Not Available

  • Royal Marsden Hospital

    London, SW3 6JJ
    United Kingdom

    Site Not Available

  • University College Hospital

    London, NW1 2PG
    United Kingdom

    Site Not Available

  • Nottingham University Hospitals Nhs Trust

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, SO16 6YD
    United Kingdom

    Site Not Available

  • Our Lady of the Lake Hospital

    Baton Rouge, Louisiana 70808-4365
    United States

    Site Not Available

  • Clinical Research Alliance, Inc

    Westbury, New York 11590-5119
    United States

    Site Not Available

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